Akkermansia Muciniphila (AKK) for Radiation-Induced Skin Injury

NCT07635277 | Recruiting Phase 1 DMC

• 2 other identifiers: 20260302002AKK-RIS-2025-V2.0
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

This study is a multicenter, open-label, Phase I single-arm clinical trial evaluating the safety and tolerability of a topical AKK probiotic preparation (Akkermansia muciniphila) for the prevention and treatment of radiation-induced skin injury in patients receiving radiotherapy for breast cancer, head and neck cancer (including nasopharyngeal carcinoma). A total of 40 participants are planned to receive the AKK preparation applied to the radiation field three times daily, starting one day before the first radiotherapy fraction and continuing until 14 days after the last fraction. The primary outcome is the incidence of grade ≥2 acute radiation dermatitis (ARD) assessed by RTOG and CTCAE criteria. Secondary outcomes include changes in skin micro-features under digital dermoscopy, skin microbiota composition, quality of life (Skindex-16), and safety.

Conditions

Radiation-Induced Skin Injury

Keywords

Acute Radiation Dermatitis; Radiation-Induced Skin Injury; Akkermansia muciniphila; AKK; Topical Probiotic; Breast Cancer; Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• Incidence of Grade ≥2 Acute Radiation Dermatitis

  Proportion of participants developing grade 2 or higher acute radiation dermatitis (ARD) as assessed by RTOG and CTCAE v6.0 criteria during radiotherapy and follow-up.

  From first radiotherapy fraction up to 90 days after the last fraction

Secondary Outcomes (7)

• Changes in Skin Micro-Features on Digital Dermoscopy

  Baseline, weekly during radiotherapy, and at days 14, 30, 60, 90 after last radiotherapy fraction.

• Skin Microbiota Composition

  Same as above.

• Frequency of Grade ≥3 Acute Radiation Dermatitis

  From first radiotherapy fraction to 90 days after last fraction.

• Duration of Grade 2/3/4 Acute Radiation Dermatitis

  During radiotherapy and up to 90 days after last fraction.

• Incidence of Grade 2 ARD at 2 Weeks Post-Radiotherapy

  Day 14 after last radiotherapy fraction.

Study Arms (1)

Experimental: AKK Topical Preparation

EXPERIMENTAL

Biological: AKK Topical Preparation

Interventions

AKK Topical Preparation BIOLOGICAL

Inactivated whole-cell Akkermansia muciniphila topical preparation. Dose: 140 µL per 25 cm² of radiation field (7 × 10⁷ CFU). Applied three times daily: once 1 hour before each radiotherapy fraction, and twice at other times (e.g., afternoon and bedtime). Treatment begins one day before the first radiotherapy fraction (after baseline skin sampling) and continues until 14 days after the last radiotherapy fraction.

Experimental: AKK Topical Preparation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of breast cancer, head and neck cancer (including nasopharyngeal carcinoma) receiving radiotherapy
• Age ≥18 years and ≤75 years, any sex
• Signed written informed consent
• Radiation field skin area can be localized and skin inflammation can be assessed
• ECOG performance status 0-1, life expectancy ≥3 months
• Adequate major organ function
• Fertile patients (both sexes) must use effective medical contraception during the study and for 6 months after the last dose
• Willing to comply with follow-up and skin image collection

You may not qualify if:

• Cognitive impairment preventing understanding of the study
• Use of antibiotics or antifungals within 1 month
• Previous treatment with other bacterial preparations
• Participation in other bacterial therapy trials
• Any abnormality (e.g., scar, tattoo) in the radiation field that would interfere with assessment
• Allergy to probiotics or any component of the study preparation; history of severe allergic reactions (e.g., anaphylaxis, angioedema, respiratory distress, allergic purpura, Arthus reaction)
• Use of immunosuppressive drugs
• Symptomatic or rapidly progressive central nervous system metastases, extensive lung metastases causing dyspnea, tumor invading major vessels or nerves
• Poorly controlled cardiac disease (NYHA class ≥2 heart failure, unstable angina, myocardial infarction within 1 year, clinically significant arrhythmia requiring treatment)
• Pregnancy or breastfeeding
• Active tuberculosis, bacterial or fungal infection (grade ≥2 per CTCAE), or HIV infection
• Substance abuse or psychiatric disorder
• Active autoimmune disease or history thereof (exceptions: vitiligo, childhood asthma fully resolved with no intervention in adulthood)
• History of alcohol or drug abuse
• Planned pregnancy from screening until 12 months after last treatment

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (2)

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

Jintang County First People's Hospital

Chengdu, Sichuan, 610400, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Biotherapy Department, Deputy Director

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: June 9, 2026
• Study Start: March 7, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CN (2)